Tissue extraction devices and methods

ABSTRACT

The tissue cutting device comprises an elongated assembly including both an outer sleeve and an inner sleeve. The outer sleeve has a tissue-receiving window, and the inner sleeve has a distal end which cuts tissue as the inner sleeve is advanced past the window. The tissue is received into a lumen of the inner sleeve, and the inner sleeve lumen is typically enlarged in a proximal direction to reduce the tendency of resected tissue to lodge therein. The tissue displacement member is optionally provided at a distal end of the outer sleeve to further aid in dislodging tissue which becomes captured in a distal end of the inner sleeve of the lumen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/460,810, filed Mar. 16, 2017; which is a continuation of U.S.application Ser. No. 14/623,186, filed Feb. 16, 2015, now U.S. Pat. No.9,636,170; which is a continuation of U.S. application Ser. No.13/531,309, filed Jun. 22, 2012, now U.S. Pat. No. 8,974,448, whichclaims the benefit of Provisional Application No. 61/501,101, filed onJun. 24, 2011, the full disclosures of which are incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates systems and methods for the cutting andextraction of uterine fibroid tissue, polyps and other abnormal uterinetissue.

BACKGROUND OF THE INVENTION

Uterine fibroids are non-cancerous tumors that develop in the wall ofuterus. Such fibroids occur in a large percentage of the femalepopulation, with some studies indicating up to 40 percent of all womenhave fibroids. Uterine fibroids can grow over time to be severalcentimeters in diameter and symptoms can include menorrhagia,reproductive dysfunction, pelvic pressure and pain.

One current treatment of fibroids is hysteroscopic resection ormyomectomy which involves transcervical access to the uterus with ahysteroscope together with insertion of a cutting instrument through aworking channel in the hysteroscope. The cutting instrument may be amechanical tissue cutter or an electrosurgical resection device such asa cutting loop. Mechanical cutting devices are disclosed in U.S. Pat.Nos. 7,226,459; 6,032,673 and 5,730,752 and U.S. Published Patent Appl.2009/0270898. An electrosurgical cutting device is disclosed in U.S.Pat. No. 5,906,615.

While hysteroscopic resection can be effective in removing uterinefibroids, many commercially available instrument are too large indiameter and thus require anesthesia in an operating room environment.Conventional resectoscopes require cervical dilation to about 9 mm. Whatis needed is a system that can effectively cut and remove fibroid tissuethrough a small diameter hysteroscope.

One particular challenge to cutting and removing fibroids using a smalldiameter hysteroscope is that resected tissue can easily become lodgedin the small diameter lumens found in such small scopes. Therefore, itwould be particularly useful to provide apparatus and methods whichreduce the likelihood of resected tissue becoming lodged in the tissueremoval lumens of such small diameter hysteroscopes. At least some ofthese objectives will be met by the inventions described herein below.

SUMMARY OF THE INVENTION

The present invention provides improved tissue cutting devices, tissueextraction devices, and methods for their use, where the likelihood ofresected tissue becoming lodged in the device is greatly reduced. Thedevices and methods may utilize one or more of a number of separatefeatures, described in details below, where the individual features maybe used independently or in combination in order to reduce thelikelihood that tissue will become lodged in even very small tissueremoval lumens used in hysteroscops and similar recectoscopes.

In a first aspect, a tissue cutting device comprises an elongatedassembly including both an outer sleeve and an inner sleeve. The outersleeve has a tissue-receiving window, typically near its distal end,which is open to an interior lumen of the outer sleeve. The inner sleeveis disposed coaxially in the lumen of the outer sleeve, and the sleevesare arranged so that the inner sleeve can reciprocate within the outersleeve so that a tissue-cutting distal end of the inner sleeve can beadvanced past the tissue-receiving window. In this way, by advancing theinner sleeve relative to the outer sleeve while tissue intrudes into theopen window, typically fibroid tissue but other tissues as well, theintruding tissue may then be resected by advancing the inner sleeve topass the cutting edge over the open window. The resected tissue isreceived through an open distal end of the inner sleeve into a distalportion of the inner sleeve lumen. Typically, a partial vacuum will bedrawn on the inner sleeve lumen, to draw the resected tissue into theinner sleeve lumen. In order to reduce the chance that the resectedtissue will become lodged in a distal portion of the inner sleeve lumen,a proximal portion of the inner sleeve lumen is provided with a crosssectional area which is larger than that of the distal portion. Theincreased in cross-sectional area need not be great, usually being atleast 5%, and sometimes being 10% or more greater.

In another aspect of the present invention, the outer sleeve lumen mayhave a distal lumen portion extending distally of the window. The distallumen portion will typically have a length which is at least as long asthe length of the distal portion of the inner sleeve lumen. In this way,the inner sleeve may be advanced past the tissue-receiving window andinto the distal lumen portion of the outer sleeve lumen. Suchadvancement not only allows a clean cut, it also allows for adisplacement feature to be disposed in the distal lumen portion of theouter sleeve to engage and dislodge the tissue in the distal portion ofthe outer sleeve lumen as the inner sleeve is advanced distally into thedistal lumen. The distance from a distal edge of the window to thedistal end of the interior passage way will typically be at least 4 mm,often being 6 mm, sometimes being 8 mm or longer. The length of thedistal lumen portion will typically be at least 5 mm, often beinglonger. Usually, the distal portion of the inner sleeve lumen will alsohave a length of at least 5 mm, typically being substantially the sameas the length of the distal lumen portion of the outer sleeve.

The tissue-cutting distal end of the inner sleeve may comprise anyconventional tissue-cutting structure, typically being a sharp-edgedblade, a radiofrequency (RF) electrode, or the like.

Further optionally, an edge of the window may be surrounded by adielectric material, typically having a width of at least 0.005 in.

Further optionally, the inner sleeve may have a first stroke portionwhich advances the tissue-cutting end across the window and a secondstroke portion which advances the tissue-cutting end beyond the window,or a length of the second stroke portion is at least 5% of the combinedlengths of the first and second stroke portions.

In a further aspect of the present invention, the tissue extractiondevice comprises a handle and a shaft assembly extending axially fromthe handle. The shaft assembly has a tissue-receiving windowcommunicating with an interior extraction lumen for extracting tissue.The shaft assembly further comprises axially-extending first and secondelements with at least one element being movable relative to the otherelement to move between a first position and a second position in orderto resect tissue received in the window. A displacement feature coupledto the shaft is configured to displace resected tissue from theextraction lumen.

The first position of the first and second elements typically comprisesan open-window configuration for receiving tissue therein. The secondposition is then a closed-window configuration, where movement of theelements from the first position toward the second position typicallycuts tissue with a cutting edge on at least one of the elements. Thecutting element will typically be a sharp-edged blade, an RF electrode,or the like. In exemplary embodiments, the displacement feature willcomprise a projecting element that extends into the extraction lumen sothat resected tissue is displaced as the elements are moved relative toeach other. The projecting element will physically engage a tissue justafter it has been resected and will act as a barrier to dislodge thetissue proximally as the cutting element is advanced further in thedistal direction. The displacement feature may have a maximumcross-sectional dimension which is sufficient to extend substantiallyacross a cross-section of the extraction lumen. In other embodiments,the displacement feature will have a cross-sectional area or “footprint”that substantially occupies the cross-section of the extraction lumen.In still other embodiments, the displacement feature may have a shapewhich is symmetric about a central axis of the extraction lumen but willnot necessarily occupy the entire cross-section of the extraction lumen.Specific examples would be axially fluted configurations, star-shapedconfigurations, and the like. In other specific embodiments, thedisplacement feature may comprise a dielectric material and may beconfigured to extend axially into the extraction lumen by a distance ofat least 2 mm, sometimes at least 4 mm, and other times at least 6 mm.In still other embodiments, the displacement feature will have across-sectional area which is at least 50% of the cross-sectional areaof the extraction lumen in the region where the displacement featureenters the lumen.

The present invention also provides methods for cutting and extractingtissue from a body cavity, such as fibroids from a uterus. The methodscomprise cutting tissue with a reciprocating inner sleeve having anextending stroke and a retracting stroke within an outer sleeve. Theextending stroke cuts and captures tissue received through atissue-receiving window in the outer sleeve. Tissue which is cut canbecome captured in a distal portion of a lumen of the inner sleeve, andif it is, the captured tissue is pushed in a proximal direction from thedistal portion of the lumen in the inner sleeve where the displacementmember, when the cutting sleeve is in a transition range between theextending stroke and the retracting stroke. The displacement member isable to push the captured tissue from the distal region into a proximalregion of the inner sleeve lumen. Typically, the proximal region of theinner sleeve lumen has a cross-sectional area which is larger than thatof the distal region of the inner sleeve lumen. This enlargement of thelumen allows the tissue to be extracted, typically by a partial vacuumapplied at a proximal end of the lumen, with a reduced risk of becomingcaught or captured. Usually, the displacement member is fixedly attachedto the outer sleeve and axially aligned with the distal portion of theinner sleeve lumen so that the captured tissue is engaged and pushedproximally into the proximal portion of the inner sleeve as the innersleeve is advanced fully into the outer sleeve. In other specificembodiments, the inner sleeve is advanced over a first stroke portionwhich advances a tissue-cutting end of the inner sleeve across thewindow and then further advanced over a second stroke portion whichcauses the tissue-cutting end to move beyond the window. The length ofthe second stroke portion is at least 5% of the combined lengths of thefirst and second stroke portions.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a plan view of an assembly including a hysteroscope and atissue-cutting device corresponding to the invention that is insertedthrough the working channel of the hysteroscope.

FIG. 2 is a schematic perspective view of a fluid management system usedfor distending the uterus and for assisting in electrosurgical tissuecutting and extraction.

FIG. 3 is a cross-sectional view of the shaft of the hysteroscope ofFIG. 1 showing various channels therein.

FIG. 4A is a schematic view of the working end of the electrosurgicaltissue-cutting device of FIG. 1 showing an outer sleeve with areciprocating inner cutting sleeve in a partially advanced position.

FIG. 4B is a schematic view of the working end of FIG. 4A with thereciprocating inner cutting sleeve in a fully advanced position.

FIG. 5 is a schematic perspective view of the working end of the innersleeve of FIG. 4 showing its electrode edge.

FIG. 6A is a schematic cut-away view of a portion of outer sleeve, innerRF cutting sleeve and a tissue-receiving window of the outer sleeve.

FIG. 6B is a schematic view of a distal end portion another embodimentof inner RF cutting sleeve.

FIG. 7A is a cross sectional view of the inner RF cutting sleeve of FIG.6B taken along line 7A-7A of FIG. 6B.

FIG. 7B is another cross sectional view of the inner RF cutting sleeveof FIG. 6B taken along line 7B-7B of FIG. 6B.

FIG. 8 is a schematic view of a distal end portion of another embodimentof inner RF cutting sleeve.

FIG. 9A is a cross sectional view of the RF cutting sleeve of FIG. 8taken along line 9A-9A of FIG. 8.

FIG. 9B is a cross sectional view of the RF cutting sleeve of FIG. 8taken along line 9B-9B of FIG. 8.

FIG. 10 is an enlarged cross sectional view of a working end with an RFcutting sleeve in advanced position and a tissue displacement memberpushing a tissue strip proximally in the extraction lumen.

FIG. 11 is a cross-sectional of a variation of the tissue displacementmember of FIG. 10.

FIG. 12 is a perspective view of another embodiment of working endhaving a tissue-receiving window with a dielectric edge.

FIG. 13 is a cross section of the tissue-receiving window of FIG. 12showing the dielectric edge and interior dielectric layer.

FIG. 14 is a perspective view of another embodiment of working end witha tissue-receiving window that has an asymmetric configuration.

FIG. 15 is a perspective view of another variation with atissue-receiving window that is configured with tissue-grippingfeatures.

FIG. 16 is a perspective view of another variation with an exteriorsleeve with a distal dielectric body portion.

DETAILED DESCRIPTION

FIG. 1 illustrates an assembly that comprises an endoscope 50 used forhysteroscopy together with a tissue-extraction device 100 extendingthrough a working channel 102 of the endoscope. The endoscope orhysteroscope 50 has a handle 104 coupled to an elongated shaft 105having a diameter of 5 mm to 7 mm. The working channel 102 therein maybe round, D-shaped or any other suitable shape. The endoscope shaft 105is further configured with an optics channel 106 and one or more fluidinflow/outflow channels 108 a, 108 b (FIG. 3) that communicate withvalve-connectors 110 a, 110 b configured for coupling to a fluid inflowsource 120 thereto, or optionally a negative pressure source 125 (FIGS.1-2). The fluid inflow source 120 is a component of a fluid managementsystem 126 as is known in the art (FIG. 2) which comprises a fluidcontainer 128 and pump mechanism 130 which pumps fluid through thehysteroscope 50 into the uterine cavity. As can be seen in FIG. 2, thefluid management system 126 further includes the negative pressuresource 125 (which can comprise an operating room wall suction source)coupled to the tissue-cutting device 100. The handle 104 of theendoscope includes the angled extension portion 132 with optics to whicha videoscopic camera 135 can be operatively coupled. A light source 136also is coupled to light coupling 138 on the handle of the hysteroscope50. The working channel 102 of the hysteroscope is configured forinsertion and manipulation of the tissue-cutting and extracting device100, for example to treat and remove fibroid tissue. In one embodiment,the hysteroscope shaft 105 has an axial length of 21 cm, and cancomprise a 0° scope, or 15° to 30° scope.

Still referring to FIG. 1, the tissue-cutting device 100 has a highlyelongated shaft assembly 140 configured to extend through the workingchannel 102 in the hysteroscope. A handle 142 of the tissue-cuttingdevice 100 is adapted for manipulating the electrosurgical working end145 of the device. In use, the handle 142 can be manipulated bothrotationally and axially, for example, to orient the working end 145 tocut targeted fibroid tissue. The tissue-cutting device 100 hassubsystems coupled to its handle 142 to enable electrosurgical cuttingof targeted tissue. A radio frequency generator or RF source 150 andcontroller 155 are coupled to at least one RF electrode carried by theworking end 145 as will be described in detail below. In one embodimentshown in FIG. 1, an electrical cable 156 and negative pressure source125 are operatively coupled to a connector 158 in handle 142. Theelectrical cable couples the RF source 150 to the electrosurgicalworking end 145. The negative pressure source 125 communicates with atissue-extraction channel 160 in the shaft assembly 140 of the tissueextraction device 100 (FIG. 4A).

FIG. 1 further illustrates a seal housing 162 that carries a flexibleseal 164 carried by the hysteroscope handle 104 for sealing the shaft140 of the tissue-cutting device 100 in the working channel 102 toprevent distending fluid from escaping from a uterine cavity.

In one embodiment as shown in FIG. 1, the handle 142 of tissue-cuttingdevice 100 includes a motor drive 165 for reciprocating or otherwisemoving a cutting component of the electrosurgical working end 145 aswill be described below. The handle 142 optionally includes one or moreactuator buttons 166 for actuating the device. In another embodiment, afootswitch can be used to operate the device. In one embodiment, thesystem includes a switch or control mechanism to provide a plurality ofreciprocation speeds, for example 1 Hz, 2 Hz, 3 Hz, 4 Hz and up to 8 Hz.Further, the system can include a mechanism for moving and locking thereciprocating cutting sleeve in a non-extended position and in anextended position. Further, the system can include a mechanism foractuating a single reciprocating stroke.

Referring to FIGS. 1 and 4A, an electrosurgical tissue-cutting devicehas an elongate shaft assembly 140 extending about longitudinal axis 168comprising an exterior or first outer sleeve 170 with passageway orlumen 172 therein that accommodates a second or inner sleeve 175 thatcan reciprocate (and optionally rotate or oscillate) in lumen 172 to cuttissue as is known in that art of such tubular cutters. In oneembodiment, the tissue-receiving window 176 in the outer sleeve 170 hasan axial length ranging between 10 mm and 30 mm and extends in a radialangle about outer sleeve 170 from about 45° to 210° relative to axis 168of the sleeve. The outer and inner sleeves 170 and 175 can comprise athin-wall stainless steel material and function as opposing polarityelectrodes as will be described in detail below. FIGS. 6A-8 illustrateinsulative layers carried by the outer and inner sleeves 170 and 175 tolimit, control and/or prevent unwanted electrical current flows betweencertain portions of the sleeve. In one embodiment, a stainless steelouter sleeve 170 has an O.D. of 0.143″ with an I.D. of 0.133″ and withan inner insulative layer (described below) the sleeve has a nominalI.D. of 0.125″. In this embodiment, the stainless steel inner sleeve 175has an O.D. of 0.120″ with an I.D. of 0.112″. The inner sleeve 175 withan outer insulative layer has a nominal O.D. of about 0.123″ to 0.124″to reciprocate in lumen 172. In other embodiments, outer and or innersleeves can be fabricated of metal, plastic, ceramic of a combinationthereof. The cross-section of the sleeves can be round, oval or anyother suitable shape.

As can be seen in FIG. 4A, the distal end 177 of inner sleeve 175comprises a first polarity electrode with distal cutting electrode edge180 about which plasma can be generated. The electrode edge 180 also canbe described as an active electrode during tissue cutting since theelectrode edge 180 then has a substantially smaller surface area thanthe opposing polarity or return electrode. In one embodiment in FIG. 4A,the exposed surfaces of outer sleeve 170 comprises the second polarityelectrode 185, which thus can be described as the return electrode sinceduring use such an electrode surface has a substantially larger surfacearea compared to the functionally exposed surface area of the activeelectrode edge 180.

In one aspect of the invention, the inner sleeve or cutting sleeve 175has an interior tissue extraction lumen 160 with first and secondinterior diameters that are adapted to electrosurgically cut tissuevolumes rapidly—and thereafter consistently extract the cut tissuestrips through the highly elongated lumen 160 without clogging.Referring to FIGS. 5 and 6A, it can be seen that the inner sleeve 175has a first diameter portion 190A that extends from the handle 142(FIG. 1) to a distal region 192 of the sleeve 175 wherein the tissueextraction lumen transitions to a smaller second diameter lumen 190Bwith a reduced diameter indicated at B which is defined by the electrodesleeve element 195 that provides cutting electrode edge 180. The axiallength C of the reduced cross-section lumen 190B can range from about 2mm to 20 mm. In one embodiment, the first diameter A is 0.112″ and thesecond reduced diameter B is 0.100″. As shown in FIG. 5, the innersleeve 175 can be an electrically conductive stainless steel and thereduced diameter electrode portion also can comprise a stainless steelelectrode sleeve element 195 that is welded in place by weld 196 (FIG.6A). In another alternative embodiment, the electrode and reduceddiameter electrode sleeve element 195 comprises a tungsten tube that canbe press fit into the distal end 198 of inner sleeve 175. FIGS. 5 and 6Afurther illustrates the interfacing insulation layers 202 and 204carried by the first and second sleeves 170, 175, respectively. In FIG.6A, the outer sleeve 170 is lined with a thin-wall insulative material200, such as PFA, or another material described below. Similarly, theinner sleeve 175 has an exterior insulative layer 202. These coatingmaterials can be lubricious as well as electrically insulative to reducefriction during reciprocation of the inner sleeve 175.

The insulative layers 200 and 202 described above can comprise alubricious, hydrophobic or hydrophilic polymeric material. For example,the material can comprise a bio-compatible material such as PFA,TEFLON®, polytetrafluroethylene (PTFE), FEP (Fluorinatedethylenepropylene), polyethylene, polyamide, ECTFE(Ethylenechlorotrifluoroethylene), ETFE, PVDF, polyvinyl chloride orsilicone.

Now turning to FIG. 6B, another variation of inner sleeve 175 isillustrated in a schematic view together with a tissue volume beingresected with the plasma electrode edge 180. In this embodiment, as inother embodiments in this disclosure, the RF source operates at selectedoperational parameters to create a plasma around the electrode edge 180of electrode sleeve 195 as is known in the art. Thus, the plasmagenerated at electrode edge 180 can cut and ablate a path P in thetissue 220, and is suited for cutting fibroid tissue and other abnormaluterine tissue. In FIG. 6B, the distal portion of the cutting sleeve 175includes a ceramic collar 222 which is adjacent the distal edge 180 ofthe electrode sleeve 195. The ceramic 222 collar functions to confineplasma formation about the distal electrode edge 180 and functionsfurther to prevent plasma from contacting and damaging the polymerinsulative layer 202 on the cutting sleeve 175 during operation. In oneaspect of the invention, the path P cut in the tissue 220 with theplasma at electrode edge 180 provides a path P having an ablated widthindicated at W, wherein such path width W is substantially wide due totissue vaporization. This removal and vaporization of tissue in path Pis substantially different than the effect of cutting similar tissuewith a sharp blade edge, as in various prior art devices. A sharp bladeedge can divide tissue (without cauterization) but applies mechanicalforce to the tissue and may prevent a large cross section slug of tissuefrom being cut. In contrast, the plasma at the electrode edge 180 canvaporize a path P in tissue without applying any substantial force onthe tissue to thus cut larger cross sections or slugs of strips oftissue. Further, the plasma cutting effect reduces the cross section oftissue strip 225 received in the tissue-extraction lumen 190B. FIG. 6Bdepicts a tissue strip to 225 entering lumen 190B which has such asmaller cross-section than the lumen due to the vaporization of tissue.Further, the cross section of tissue 225 as it enters the largercross-section lumen 190A results in even greater free space 196 aroundthe tissue strip 225. Thus, the resection of tissue with the plasmaelectrode edge 180, together with the lumen transition from the smallercross-section (190B) to the larger cross-section (190A) of thetissue-extraction lumen 160 can significantly reduce or eliminate thepotential for successive resected tissue strips 225 to clog the lumen.Prior art resection devices with such small diameter tissue-extractionlumen typically have problems with tissue clogging.

In another aspect of the invention, the negative pressure source 225coupled to the proximal end of tissue-extraction lumen 160 (see FIGS. 1and 4A) also assists in aspirating and moving tissue strips 225 in theproximal direction to a collection reservoir (not shown) outside thehandle 142 of the device.

FIGS. 7A-7B illustrate the change in lumen diameter of cutting sleeve175 of FIG. 6B. FIG. 8 illustrates the distal end of a variation ofcutting sleeve 175′ which is configured with an electrode cuttingelement 195′ that is partially tubular in contrast to the previouslydescribed tubular electrode element 195 (FIGS. 5 and 6A). FIGS. 9A-9Bagain illustrate the change in cross-section of the tissue-extractionlumen between reduced cross-section region 190B′ and the increasedcross-section region 190A′ of the cutting sleeve 175′ of FIG. 8. Thus,the functionality remains the same whether the cutting electrode element195′ is tubular or partly tubular. In FIG. 8, the ceramic collar 222′ isshown, in one variation, as extending only partially around sleeve 175to cooperate with the radial angle of cutting electrode element 195′.Further, the variation of FIG. 8 illustrates that the ceramic collar222′ has a larger outside diameter than insulative layer 202. Thus,friction may be reduced since the short axial length of the ceramiccollar 222′ interfaces and slides against the interfacing insulativelayer 200 about the inner surface of lumen 172 of outer sleeve 170.

In general, one aspect of the invention comprises a tissue cutting andextracting device (FIGS. 4A-4B) that includes first and secondconcentric sleeves having an axis and wherein the second (inner) sleeve175 has an axially-extending tissue-extraction lumen therein, andwherein the second sleeve 175 is moveable between axially non-extendedand extended positions relative to a tissue-receiving window 176 infirst sleeve 170 to resect tissue, and wherein the tissue extractionlumen 160 has first and second cross-sections. The second sleeve 175 hasa distal end configured as a plasma electrode edge 180 to resect tissuedisposed in tissue-receiving window 176 of the first sleeve 170.Further, the distal end of the second sleeve, and more particularly, theelectrode edge 180 is configured for plasma ablation of a substantiallywide path in the tissue. In general, the tissue-extraction device isconfigured with a tissue extraction lumen 160 having a distal endportion with a reduced cross-section that is smaller than across-section of medial and proximal portions of the lumen 160.

In one aspect of the invention, referring to FIGS. 7A-7B and 9A-9B, thetissue-extraction lumen 160 has a reduced cross-sectional area in lumenregion 190A proximate the plasma cutting tip or electrode edge 180wherein said reduced cross section is less than 95%, 90%, 85% or 80%than the cross sectional area of medial and proximal portions 190B ofthe tissue-extraction lumen, and wherein the axial length of thetissue-extraction lumen is at least 10 cm, 20 cm, 30 cm or 40 cm. In oneembodiment of tissue-cutting device 100 for hysteroscopic fibroidcutting and extraction (FIG. 1), the shaft assembly 140 of thetissue-cutting device is 35 cm in length.

Now referring to FIGS. 4A-4B and FIG. 10, one aspect of the inventioncomprises a “tissue displacement” mechanism that is configured todisplace and move tissue strips 225 (see FIG. 10) in the proximaldirection in lumen 160 of cutting sleeve 175 to thus ensure that tissuedoes not clog the lumen of the inner sleeve 175. As can be seen in FIGS.4A, 4B and 10, one tissue displacement mechanism comprises a projectingelement 230 that extends proximally from distal tip or body 232 that isfixedly attached to outer sleeve 170. The projecting element 230 extendsproximally along central axis 168 in a distal chamber 240 defined byouter sleeve 170 and the interior surface of the distal tip 232. In oneembodiment depicted in FIGS. 4A and 10, the shaft-like projectingelement 230 thus functions as a plunger or pusher member and can push acaptured tissue strip 225 in the proximal direction from the smallcross-section lumen 190B of cutting sleeve 175 as the cutting sleeve 175moves to its fully advanced or extended position (see. FIG. 10). Forthis reason, the length D of the projecting element 230 is at least asgreat as the axial length E of the small cross-section lumen 190B in thecutting sleeve. Further, as depicted in FIG. 10, the stroke Y of thecutting sleeve 175 extends at least about 3 mm, 4 mm or 5 mm distallybeyond the distal edge of the window 290. In another aspect, the strokeY of the cutting sleeve 175 is at least 5% or 10% of the total stroke ofthe cutting sleeve (stroke X+stroke Y in FIG. 10).

In general, a method of cutting tissue corresponding to the inventioncomprising cutting tissue with a reciprocating cutting sleeve having anextending stroke and a retracting stroke within an outer sleeve, whereinthe extending stroke cuts and captures tissue received by atissue-receiving window in the outer sleeve, and pushing the capturedtissue in the proximal direction in the cutting sleeve with adisplacement member when the cutting sleeve is in a transition range inwhich the cutting sleeve transitions from the extending stroke to theretracting stroke. Further, the displacement member is configured topush the captured tissue at least in part from a first smallercross-section lumen to a second larger cross-section lumen in thecutting sleeve. Thereafter, the negative pressure source can moreeffectively extract and aspirate the tissue from the lumen.

In another aspect of the invention, the tissue cutting device comprisesan elongated assembly comprising concentric outer and inner sleeves,with a tissue-receiving window in the outer sleeve open to an interiorlumen with a distal lumen portion extending distal to the window,wherein the inner sleeve is configured with a first axially-extendingchannel having a lesser cross-sectional area and a secondaxially-extending channel portion having a second greatercross-sectional area and wherein the ratio of lengths of the distallumen portion relative to the first channel is at least 1:1. In oneembodiment, the device is configured with a length of the distal lumenportion that is at least 5 mm. In this embodiment, the length of firstaxially-extending channel is at least 5 mm.

In another aspect of the invention, a tissue cutting device is comprisedof an elongated assembly comprising concentric outer and inner sleeves,with a tissue-receiving window in the outer sleeve open to an interiorlumen with a distal lumen portion extending distal to the window,wherein the ratio of the length of the distal lumen portion relative tothe diameter of the interior lumen is at least 1:1. In one embodiment,the ratio is at least 1.5:1. In this embodiment, the length of thedistal lumen portion is at least 5 mm. In one variation, the diameter ofthe interior lumen is less than 5 mm.

In general, a tissue cutting device comprised of a handle coupled to anelongated tubular assembly comprising outer and inner concentricsleeves, a tissue-receiving window in the outer sleeve communicatingwith an interior passageway extending through the assembly wherein adistal edge of the window is a spaced at least 4 mm, 6 mm, 8 mm or 10 mmfrom the distal end of the interior passageway. In this variation, themean cross section of the passageway is less than 5 mm, 4 mm or 3 mm.

One embodiment of a tissue cutting device comprises a handle coupled toan axially-extending shaft assembly defining a tissue-receiving windowcommunicating with an interior extraction lumen for extracting tissue,the shaft assembly comprising axially-extending first and secondelements with at least one element axially moveable relative to theother element between a first position and a second position, and adisplacement feature configured to displace resected tissue from theextraction lumen. In this embodiment, the first position comprises anopen-window configuration for receiving tissue therein and the secondposition is a closed-window configuration. The movement of the elementsfrom the first position toward the second position cuts tissue with acutting edge of an element. The cutting edge can comprise a sharp bladeedge or an RF electrode edge. The displacement feature (FIG. 4A) orprojecting element 230 can be coupled to the first element, can projectaxially relative to an axis of the extraction lumen. This embodiment isconfigured with an extraction lumen having first and secondcross-sectional areas, wherein a distal region of the extraction lumenhas a first lesser cross-sectional area and a medial portion of theextraction lumen has a second greater cross-sectional area. In onevariation, the distal region of the extraction lumen having the firstcross-sectional area extends axially at least 2 mm, 4 mm, 6 mm and 8 mm.In another variation, the displacement feature is configured to extendaxially into the extraction lumen in the second closed-windowconfiguration at least 2 mm, 4 mm, 6 mm and 8 mm.

In general, the displacement feature or projecting element 230 has amaximum cross-section that extends substantially across a cross-sectionof the extraction lumen. In one variation, the displacement feature hasa cross-sectional area that substantially occupies the firstcross-sectional area of the extraction lumen. FIGS. 4A and 10 illustratea projecting element 230 that is cylindrical. FIG. 11 illustrates asection of a projecting element 230′ that has a symmetric shape relativeto a central axis of the extraction lumen, and is star-shaped or flutedwith ribs and channels to allow distension fluid to flow therethrough asthe cutting sleeve 175 reciprocates in chamber 240. In anotherembodiment, the projecting element can have an asymmetric crosssectional shape with any number or flutes, grooves, lumens or boreextending about its axis. In a typical embodiment, the projectingelement 230 is a dielectric such as a ceramic or polymer.

In another embodiment depicted in FIGS. 12-13, the tissue cutting deviceagain comprises an elongated assembly comprising concentric outer andinner sleeves, with a tissue-receiving window in the outer sleeve opento an interior lumen. In this embodiment, the edges of the windowcomprise a dielectric element 300 such as a polymer or ceramic that canbe molded, formed and bonded around the edge of window 176 in the metalsleeve 170. This prevents unwanted arcing from the electrode edge 180 tothe exterior of sleeve 170 (or electrode 185) when plasma is generatedat the electrode edge 180 during reciprocation. The width W (FIG. 13) ofthe dielectric is at least 0.005″. FIG. 13 illustrates a sectional viewof an outer sleeve 170 at the window 176 comprising a conductiveelectrode and dielectric element 300 around the edge of the window. Itcan be seen that thin insulative layer 200 is configured to join andbond to the dielectric element 300.

FIG. 14 depicts the working end of another embodiment of tissue cuttingdevice similar to those described above with a window 310 opening to theinterior bore 172 of outer sleeve 170 wherein the longitudinal window310 is longitudinally asymmetrical and wherein the window depthincreases in the distal direction. As can be understood from FIG. 10,the asymmetric window 310 of FIG. 13 draws a lesser volume tissue intothe proximal window portion and a greater volume of tissue into thedistal window portion for cutting with electrode edge 190. Thus, thiswindow configuration allows for a lesser cross section of tissue strip225 in the proximal direction and a greater cross section of tissuestrip 225 in the distal direction. The variation in cross-section of thecaptured tissue increases the efficiency of the negative pressure source225 (FIG. 1) in applying effective aspiration forces on the tissue strip225 in the lumen, which is further assisted by projecting member 230which is configured to push the distal, greater cross-sectional end oftissue strip 225 in the lumen 160 of inner sleeve 175.

Further, still referring to FIG. 14, the increased radius R allowed bythe varied depth window 310 allow for greater strength of the assemblyin the proximal region of the window as the outer sleeve 270 transitionsto the full hoop strength of the sleeve.

FIG. 15 depicts another working end variation similar to those describedabove with a window 320 opening to interior bore 172 of outer sleeve170. In this embodiment, the longitudinal window 320 has an edgeconfigured with gripping features 322 such as teeth or an abrasivesurface which assist in maintaining tissue 220 (see FIG. 10) in anon-sliding disposition as the cutting sleeve 175 is moving in itsextending stroke.

FIG. 16 depicts another working end variation similar to those describedabove with a window 330 opening to interior bore 172 of outer sleeve170. In this embodiment, a distal body 332 of a dielectric is bonded tothe sleeve to thus provide distal window edge 333 that is entirely ofnon-conductive material. The body 332 can comprise a ceramic orpolymeric material that is useful in preventing plasma at thereciprocating electrode edge 180 (see FIG. 10) of the cutting sleeve 170from folding, flexing, abrading, delaminating or otherwise damaging thedielectric lining or layer 200 laminated in bore 172 of sleeve 170.

FIG. 16 further depicts a marking 340 that marks the proximal end ofwindow 320 opening to interior bore 172 of outer sleeve 170. Thismarking is useful for orienting and to rotating the working end 145 whenviewing through the hysteroscope and the physician presses the windowinto contact with tissue. Further, the working end has another marker(not visible) on the exterior of outer sleeve 180 to further orient thephysician to the window.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

What is claimed is:
 1. A tissue resecting device, comprising: an outersleeve having a tissue-receiving window opening into a lumen of theouter sleeve; and an axially reciprocating inner sleeve disposed withinthe lumen of the outer sleeve and having a tissue-resecting distal end;wherein the outer sleeve includes a distal tip fixedly attached to adistal end of the outer sleeve and a projecting element extendingproximally from the distal tip; wherein the tissue-receiving window islongitudinally asymmetrical.
 2. The tissue resecting device of claim 1,wherein a depth of the tissue-receiving window from an outer surface ofthe outer sleeve varies along a length of the tissue-receiving window.3. The tissue resecting device of claim 2, wherein the depth of thetissue-receiving window increases in a distal direction.
 4. The tissueresecting device of claim 1, wherein the tissue-resecting distal end hasa first cross-sectional area less than a second cross-sectional area ata portion of the inner sleeve proximal of the tissue-resecting distalend.
 5. The tissue resecting device of claim 4, wherein the projectingelement has a maximum cross-sectional area that extends substantiallyacross the first cross-sectional area.
 6. The tissue resecting device ofclaim 1, wherein the projecting element has a substantially symmetricshape.
 7. The tissue resecting device of claim 1, wherein the projectingelement comprises ribs and channels extending longitudinally.
 8. Thetissue resecting device of claim 1, wherein a lumen of the inner sleeveis in fluid communication with a negative pressure source configured toaspirate resected tissue therethrough.
 9. The tissue resecting device ofclaim 1, wherein an edge of the tissue-receiving window is configuredwith gripping features.
 10. The tissue resecting device of claim 9,wherein the edge includes teeth or an abrasive surface.
 11. A tissueresecting device, comprising: an outer sleeve having a longitudinallyasymmetrical tissue-receiving window opening into a lumen of the outersleeve; and an inner sleeve slidably disposed within the lumen of theouter sleeve and having a tissue-resecting distal end, wherein a lumenof the inner sleeve is in fluid communication with a negative pressuresource configured to aspirate resected tissue through the lumen of theinner sleeve; wherein the outer sleeve includes a distal tip fixedlyattached to a distal end of the outer sleeve and a tissue displacementfeature extending proximally from the distal tip; wherein the tissuedisplacement feature extends proximal of a distal end of thetissue-receiving window.
 12. The tissue resecting device of claim 11,wherein the inner sleeve has a first cross-sectional area extending froma proximal end of the inner sleeve to a distal region of the innersleeve.
 13. The tissue resecting device of claim 12, wherein thetissue-resecting distal end defines a second cross-sectional areasmaller than the first cross-sectional area.
 14. The tissue resectingdevice of claim 13, wherein a length of the tissue displacement featureis at least as long as an axial length of the second cross-sectionalarea defined by the tissue-resecting distal end.
 15. The tissueresecting device of claim 11, wherein a distal portion of thetissue-receiving window defines a larger opening into the lumen of theouter sleeve than a proximal portion of the tissue-receiving window. 16.A tissue resecting device, comprising: an outer sleeve having atissue-receiving window opening into a lumen of the outer sleeve; and aninner sleeve slidably disposed within the lumen of the outer sleeve andconfigured to shift between an open window position and a closed windowposition, the inner sleeve having a tissue-resecting distal end and aninterior lumen in fluid communication with a negative pressure sourcefor aspiration of resected tissue through the interior lumen; whereinthe outer sleeve includes a closed distal tip at a distal end of theouter sleeve and a tissue displacement feature extending proximally fromthe closed distal tip; wherein the tissue-receiving window extendsaround a portion of a circumference of the outer sleeve, and a distalportion of the tissue-receiving window extends further around thecircumference of the outer sleeve than a proximal portion of thetissue-receiving window.
 17. The tissue resecting device of claim 16,wherein the tissue-resecting distal end extends distally of thetissue-receiving window in the closed window position.
 18. The tissueresecting device of claim 17, wherein the tissue displacement featureextends into the interior lumen in the closed window position.
 19. Thetissue resecting device of claim 16, wherein the tissue-resecting distalend includes an RF electrode operatively coupled to an RF sourceconfigured to create a plasma around an edge of the RF electrode. 20.The tissue resecting device of claim 16, further comprising a motordrive configured to axially reciprocate the inner sleeve between theopen window position and the closed window position.